Brief Title
The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia
Official Title
The Use of the LuViva Advanced Cervical Scan to Identify Women at High-Risk for Cervical Neoplasia
Brief Summary
This study is designed to demonstrate that a multimodal hyperspectral device (LuViva) is able
to segregate women with abnormal screening tests into Low and High risk groups for the
purpose of determining whether they require enhanced colposcopy and additional biopsies in
order to increase detection of CIN2+ cervical disease.
Detailed Description
This study is a matched pair design, single-arm study with the following two treatments:
current standard of care (SOC) and the LuViva study device. After undergoing the LuViva test,
all study subjects will first undergo the SOC (i.e., nominal) colposcopy, with the
colposcopist noting on the case report form (CRF), locations of lesions with colposcopy
impression of CIN1+. Then the colposcopist will employ enhanced colposcopy measures that
include the use on Lugol's solution and green/blue filters. The colposcopist will note on the
CRF any additional lesions that became evident as a result of these enhanced measures,
regardless of colposcopic impression. Biopsies of these lesions will be taken. Biopsies
identified using SOC practices will be placed in vials labeled "SOC Biopsy Samples". Biopsies
identified using enhanced practices will be placed in vials labeled "Enhanced Biopsy
Samples". The colposcopist will then take a biopsy from any quadrant at the squamocolumnar
junction (SCJ) in which a lesion was not observed. These biopsies will be placed in a third
vial labeled "Random Biopsy Samples". Additionally, in the instances when the SCJ is not
completely visible, an endocervical curettage (ECC) will be taken and placed in a vial
labeled "ECC Biopsy Samples". The study is a matched pair design because all subjects are
tested with the LuViva device and all will undergo both the nominal (minimal) colposcopy and
biopsy treatment pursuant to ASCCP Guidelines as well as enhanced colposcopy and biopsy. By
analyzing all biopsy specimens from SOC procedures and enhanced procedures, it can be
determined 1) Whether enhanced procedures can be justified when the LuViva test indicates
High-risk by the increase in detection of CIN2+ and 2) That when LuViva indicates Low-risk,
that enhanced procedures (in the absence of a LuViva High-risk result) are not the reason for
increased detection of CIN2+. Subjects will be enrolled during their normally scheduled
colposcopy visit and will be recruited from the pool of patients that are referred to
colposcopy based on the ASCCP Guidelines published in April 2020. The total number of
enrolled female subjects pooled across all clinical sites combined will not exceed 500 in
order to target an evaluable cohort of approximately 400 women.
Study Type
Interventional
Primary Outcome
Sensitivity of Diagnostic Device
Secondary Outcome
Specificity of Diagnostic Device
Condition
Cervical Dysplasia
Intervention
LuViva Advanced Cervical Scan
Study Arms / Comparison Groups
Singe-arm Study
Description: Experimental device being evaluated for sensitivity and specificity.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
400
Start Date
April 2023
Completion Date
March 31, 2024
Primary Completion Date
March 31, 2024
Eligibility Criteria
Inclusion Criteria:
- Able to read or understand and give informed consent
- Referral Pap test within 120 days
- Scheduled for colposcopy based on the 2019 ASCCP Management Guidelines that fall
within the 4% to 59% Immediate CIN3+ risk with the exception of women who lack a
cervix or may be pregnant and are recommended to colposcopy.*
- Notes: The rationale for defining the referral inclusion criteria as women
scheduled for colposcopy is that this group has been identified with having a
significant likelihood of being diagnosed with CIN2+ over the two year period
after being referred to colposcopy because of an abnormal screening test or
tests. For example, the ALTS results showed that women with ASC-US plus high-risk
HPV, LSIL, ASC-H, AGC and HSIL all had a likelihood of CIN2+ of approximately 10%
to 20% or greater in the cases of ASC-H and HSIL (5). More recently, it has been
shown that this threshold also carries with it a 4% or greater likelihood of
immediate CIN3+ (12).
Exclusion Criteria:
- Pregnancy
- Menstruating on the day of colposcopy and LuViva test
- Radiation therapy to her genitourinary system within 1 year
- Prior hysterectomy in which cervix was removed
- Congenital anatomical cervical variant (e.g., double cervix)
- Friable cervix at the time of the study (i.e., a cervix that bleeds easily upon
minimal contact or trauma)
- Post-coital or other significant bleeding at the time of the exam
- Excessive cervical mucous or discharge that cannot be removed and is significant
enough, in the opinion of the Investigator, to interfere with a Pap test or
colposcopy, resulting from inflammation, bacterial infection or other sources
- History of any photosensitizing disease or other disease affected by Ultra-violet
radiation, (e.g., pophyria, Lupus Erythematosus).
- Undergoing phototherapy
- Recent use of photosensitizing agents, such as fluoroquinolones or retinoids
- Under-screened populations - defined as those women who have not been screened within
the past 5 years who also screen positive for any HPV genotype
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, 770-634-4427, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04915495
Organization ID
CC-03-01-2020
Responsible Party
Sponsor
Study Sponsor
Guided Therapeutics
Study Sponsor
, ,
Verification Date
February 2023